Niopam 300, Solution for injection, glass bottles

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Iopamidol

Fáanlegur frá:

Bracco Imaging spa

ATC númer:

V08AB; V08AB04

INN (Alþjóðlegt nafn):

Iopamidol

Skammtar:

300 milligram(s)

Lyfjaform:

Solution for injection

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

Watersoluble, nephrotropic, low osmolar X-ray contrast media; iopamidol

Leyfisstaða:

Marketed

Leyfisdagur:

1983-03-10

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
NIOPAM 300 SOLUTION FOR INJECTION
(Iopamidol)
The name of your medicine is Niopam 300 solution for injection, which
will be called Niopam
throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet, see section 4.
WHAT IS IN THIS LEAFLET
:
1. What Niopam is and what it is used for
2. What you need to know before you are given Niopam
3. How you are given Niopam
4. Possible side effects
5. How to store Niopam
6. Contents of the pack and other information
1. WHAT IS NIOPAM AND WHAT IT IS USED FOR
Niopam is a special dye (or contrast agent) which blocks X-rays
because it contains iodine. Niopam
works by helping your doctor to see the internal body structures on an
X-ray picture. Your doctor
has prescribed Niopam to help view the blood vessels, joint and spine
or brain using X-rays.
This medicine is for diagnostic use only.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NIOPAM
YOU SHOULD NOT BE GIVEN NIOPAM IF YOU:
• Are allergic to Iopamidol, or any other ingredients of this
medicine (listed in Section 6)
TAKE SPECIAL CARE WITH NIOPAM AND TELL YOUR DOCTOR IF YOU HAVE ANY OF
THE FOLLOWING
CONDITIONS:
• A history of allergy or asthma
• Diabetes
• Heart problems
• High blood pressure in the lungs
• Kidney or liver problems
• Over-active thyroid gland (this is particularly important in
newborn babies)
• A history of epilepsy
• Myelomatosis (Cancer of the plasma cells in the blood)
• Severe systemic disease (a disease affecting more than one part or
organ of the body)
• Sickle cell disease

Vara einkenni

Health Products Regulatory Authority
13 March 2023
CRN00DGL8
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Niopam 300, Solution for injection, glass bottles
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution contains 61.24%w/v Iopamidol, equivalent to 300mg
iodine/ml
Each ml contains 612.4mg Iopamidol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
X‑ray contrast medium for use in thoraco-lumbar and cervical
myelography, and in computer tomography enhancement.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Intrathecal
Intraventricular
Intra-arterial
Intravenous
Intra-cisternal
Intra-articular.
Posology
NIOPAM 300: DOSAGE SCHEDULE
Procedure
Dosage
Lumbar Myelography
Adults 5 - 10 ml
Thoraco-Cervical Myelography
Adults 5 - 10 ml
Orbital venography and cavernous sinography
Adults 10ml*
Ventriculography and basal cisternography
Adults 5ml
Cerebral Angiography
Adults 5 - 10 ml *
Children 5 – 7ml**
Peripheral Arteriography
Adults 20 - 50 ml *
Children **
Health Products Regulatory Authority
13 March 2023
CRN00DGL8
Page 2 of 11
Venography
Adults 20 - 50 ml *
Children **
Intravenous Urography
Adults 40 - 80 ml
1.5 ml/kg on renal
impairment
Children 1 - 2.5 ml/kg or **
Arthrography
Adults 1 - 10 ml
Computer Tomography Enhancement
Adults:
Brain scanning 5 - 100ml
intravenously
Whole body scanning 40-100ml
intravenously
* Repeat as necessary;
** According to body size and age
Elderly: dosage as for adults.
The dosage must be adapted to the examination, the age, body weight,
cardiac output, renal function, general condition of the
patient and the technique used. Usually the same iodine concentration
and volume are used with other iodinated x-ray
contrast in current use.
As with all contrast media, the lowest dose necessary to obtain
adequate visual